Ranitidine bismuth citrate-based triple therapy for seven days, with or without further anti-secretory therapy, is highly effective in patients with duodenal ulcer and Helicobacter pylori infection

OBJECTIVE: To compare the efficacy of two protocols for the eradication of Helicobacter pylori infection and the healing of active duodenal ulcer: (i) ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days, and (ii) the same triple therapy followed by 3 weeks of anti-secretory drug treatment. METHODS: The study comprised 102 patients with active duodenal ulcer and H. pylori infection; the patients were randomized to open treatment with either RBC 400 mg b.d. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 7 days, or the same treatment followed by 3 weeks of RBC 400 mg b.d. alone. Ulcer healing was confirmed by endoscopy. H. pylori eradication was assessed by endoscopy, rapid urease test and histology. RESULTS: The ulcer healed in 48/50 patients on RBC-based triple therapy alone (96.0%) and in 51/52 patients on triple therapy plus further anti-secretory treatment (98.1%). On an intention-to-treat basis, H. pylori had been successfully eradicated in 42/50 patients on triple therapy (84.0%) and in 44/52 patients on triple therapy plus anti-secretory treatment (84.6%), while by per protocol analysis the H. pylori eradication rates were 91.3% (42/46) and 89.8% (44/49), respectively. CONCLUSIONS: One-week triple therapy with RBC, amoxycillin and clarithromycin is highly effective in eradicating H. pylori and healing duodenal ulcers, even if not followed by anti-secretory drug treatment.     

Effect of triple therapy (antibiotics plus bismuth) on duodenal ulcer healing. A randomized controlled trial.

OBJECTIVE: To determine whether antimicrobial therapy for Helicobacter pylori infection accelerates the healing of duodenal ulcers. DESIGN: Single-blind, randomized, controlled trial. SETTING: Veterans Affairs hospital. PARTICIPANTS: One hundred and five patients with endoscopically verified duodenal ulcers. INTERVENTION: Patients received either ranitidine, 300 mg/d, or ranitidine, 300 mg/d, plus "triple therapy" (2 g/d of tetracycline, 750 mg/d of metronidazole, and 5 or 8 bismuth subsalicylate tablets per day). Triple therapy was administered for only the first 2 weeks of ulcer treatment. MEASUREMENTS: Videoendoscopic assessment of ulcer status was done until ulcer healing was complete. Evaluations were done after 2, 4, 8, 12, and 16 weeks of therapy. MAIN RESULTS: Ulcer healing was more rapid in patients receiving ranitidine plus triple therapy than in patients receiving ranitidine alone (P less than 0.01). The cumulative percentages of patients with healed ulcers in the group receiving ranitidine plus triple therapy and in the group receiving ranitidine alone were as follows: 37% and 18% after week 2; 74% and 53% after week 4; 84% and 68% after week 8; 96% and 80% after week 12; and 98% and 84% after week 16. CONCLUSION: Combined therapy with anti-H. pylori agents and ranitidine was superior to ranitidine alone for duodenal ulcer healing. Our results indicate that H. pylori plays a role in duodenal ulcer disease.     

Effect of treatment of Helicobacter pylori infection on the long-term recurrence of gastric or duodenal ulcer. A randomized, controlled study.

OBJECTIVE: To determine the effect of treating Helicobacter pylori infection on the recurrence of gastric and duodenal ulcer disease. DESIGN: Follow-up of up to 2 years in patients with healed ulcers who had participated in randomized, controlled trials. SETTING: A Veterans Affairs hospital. PARTICIPANTS: A total of 109 patients infected with H. pylori who had a recently healed duodenal (83 patients) or gastric ulcer (26 patients) as confirmed by endoscopy. INTERVENTION: Patients received ranitidine, 300 mg, or ranitidine plus triple therapy. Triple therapy consisted of tetracycline, 2 g; metronidazole, 750 mg; and bismuth subsalicylate, 5 or 8 tablets (151 mg bismuth per tablet) and was administered for the first 2 weeks of treatment; ranitidine therapy was continued until the ulcer had healed or 16 weeks had elapsed. After ulcer healing, no maintenance antiulcer therapy was given. MEASUREMENTS: Endoscopy to assess ulcer recurrence was done at 3-month intervals or when a patient developed symptoms, for a maximum of 2 years. RESULTS: The probability of recurrence for patients who received triple therapy plus ranitidine was significantly lower than that for patients who received ranitidine alone: for patients with duodenal ulcer, 12% (95% CI, 1% to 24%) compared with 95% (CI, 84% to 100%); for patients with gastric ulcer, 13% (CI, 4% to 31%) compared with 74% (44% to 100%). Fifty percent of patients who received ranitidine alone for healing of duodenal or gastric ulcer had a relapse within 12 weeks of healing. Ulcer recurrence in the triple therapy group was related to the failure to eradicate H. pylori and to the use of nonsteroidal anti-inflammatory drugs. CONCLUSIONS: Eradication of H. pylori infection markedly changes the natural history of peptic ulcer in patients with duodenal or gastric ulcer. Most peptic ulcers associated with H. pylori infection are curable.     

Duodenal ulcer healing rates in a one-year follow-up study with ranitidine bismuth citrate and antibiotics

BACKGROUND/AIMS: The aim of this study was to determine the one-year outcome of an eradication therapy with ranitidine bismuth citrate and antibiotics in Helicobacter pylori-positive duodenal ulcer patients in respect to ulcer and Helicobacter pylori relapse rates. METHODOLOGY: This multicenter, randomized, double-blind study involved 648 duodenal ulcer patients and had been carried out to compare the following regimens: ranitidine bismuth citrate b.i.d. co-prescribed with either clarithromycin 250 mg q.i.d. or clarithromycin 500 mg b.i.d. or clarithromycin 500 mg b.i.d. plus metronidazole 400 mg b.i.d. for 2 weeks, followed by a further 14 days of treatment with ranitidine bismuth citrate 400 mg b.i.d. to facilitate ulcer healing. H. pylori eradication was assessed by 13C-urea breath test and histology at least 4 weeks, 26 weeks and 52 weeks after the end of treatment. Ulcer relapse and H. pylori status were assessed 4 weeks, 26 weeks and 52 weeks post-treatment or if ulcer symptoms recurred. For the remainder of the follow-up period only serious adverse events were collected. RESULTS: At 12 months data of 438 (69%) patients were evaluable. The observed H. pylori eradication rates were 88-91%. H. pylori relapse rates were 2.1% after 26 weeks and 3.9% after 52 weeks. At the week 26 visit 26 patients (5.6%) and at the week 52 visit 25 patients (5.7%) had documented gastroesophageal reflux disease. CONCLUSIONS: Our data confirm the reduction of duodenal ulcer relapses after the cure of Helicobacter pylori infection.     

One-week low-dose triple therapy without anti-acid treatment has sufficient efficacy on Helicobacter pylori eradication and ulcer healing

BACKGROUND/AIMS: The aim of this study was to determine the efficacy of a 1-week low-dose proton pump inhibitor-based triple therapy without further acid suppression for cure of Helicobacter pylori infection and the ulcer healing in peptic ulcer disease. METHODOLOGY: Patients with endoscopically proven peptic ulcers who were H. pylori positive participated in this study. All patients were treated for 1 week with omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d., then patients were treated randomly for another 4 weeks with either omeprazole 20 mg once daily (OCM-O group; n = 40) or without acid suppressing agents (OCM group; n = 39). Patients were investigated endoscopically for H. pylori and ulcer status before treatment, four weeks (week 5) and 8 weeks later (week 9) after anti-H. pylori treatment. H. pylori infection was assessed by rapid urease test and histology. RESULTS: The eradication rates of H. pylori were 72.5% (95% CI: 59-86%) and 76.3% (95% CI: 63-90%) by intention-to-treat analysis and by per protocol analysis respectively in the OCM-O group and were 87.2% (95% CI: 77-98%) and 97.1% (95% CI: 92-100%) by intention-to-treat analysis and by per protocol analysis respectively in the OCM group (p < 0.05 in per protocol analysis). In respect to ulcer healing status at week 5, 89.5% (34/38) of patients in the OCM-O group and 80% (28/35) of patients in the OCM group had healed ulcers; at week 9, 86.8% (33/38) of patients in the OCM-O group and 88.6% (31/35) of patients in the OCM group had healed ulcers (p = NS). When the ulcer status was analyzed in relation to the H. pylori status, at week 5 ulcer had healed in 84.4% (54/64) of patients with clearance of H. pylori infection and in 88.9% (8/9) of those with persistent infection. At week 9, ulcer healing increased up to 93.8% (60/64) of patients with clearance of H. pylori infection and decreased to 44.4% (4/9) of patients with persistent infection. The adverse events (20%) were mild in these two treatment groups and no patients required discontinuation of the study medications. CONCLUSIONS: Continuation of antisecretory drug therapy beyond a one-week low-dose triple therapy consisting of omeprazole, clarithromycin and tinidazole is actually excessive regarding eradication efficacy and peptic ulcer healing.     

Helicobacter pylori eradication versus one-year maintenance therapy: effect on relapse and gastritis outcome.

OBJECTIVE: The aim of this study was to determine ulcer healing and H. pylori eradication rates obtained with triple therapy (omeprazole, amoxicillin and clarithromycin). Ulcer relapsing rate one year after eradication was also assessed. Maintenance therapy with placebo was compared with ranitidine therapy and the effect of eradication on histological variables of the gastric mucosa was studied. METHODS: A prospective, double-blind parallel study was performed in 85 patients endoscopically diagnosed of duodenal ulcer H. pylori positive. Patients were randomized to a 7-days triple therapy (group A) or omeprazole plus antibiotic placebo (group B). All patients were treated only with omeprazole for the next three weeks. Patients with ulcer healing after treatment were entered in a one-year follow up phase with ranitidine placebo (group A) or ranitidine (group B). Endoscopy and biopsies were performed at baseline, after treatment (5 weeks) and after 12 months of follow-up or when relapsing symptoms appeared. RESULTS: Healing rate was 90.2% in group A and 85.7% in group B. Eradication rate was 78% in group A and 0% in group B. Out of 37 healed patients in group A, eradication was achieved in 29 and only one relapse was found (3.4%). Three out of eight patients with healing but without eradication relapsed at 12 months (35%) (p < 0.05). Histopathological results showed statistically significant differences (p < 0.05) between eradicated and non eradicated patients in terms of severity of inflammation and intestinal metaplasia, but not in terms of atrophy. CONCLUSIONS: H. pylori eradication is useful to prevent ulcer relapse and to improve gastric mucosa status.     

不同疗程三联方案根除幽门螺杆菌后的复发情况

目的观察不同疗程奥美拉唑三联方案根除幽门螺杆菌(Hp)后的复发率。方法Hp阳性的干二指肠溃疡103例患者,随机分为二组:A组50例;B组53例。均给予奥美拉唑20 mg(每日2次)、阿莫西林1.0 g(每日2次)、呋喃唑酮0.1 g(每日3次),A组疗程2周,B组疗程1周。观察2组Hp根除率、溃疡复发率、3年Hp复发率及不良反应。结果A组Hp根除率、溃疡愈合率、Hp根除者3年累积复发率分别为92.0%、96.0%、8.7%;B组分别为88.7%、92.5%、12.8%,两组三项差异均无显著性(P>0.05)。结论1周和2周疗程方案近、远期疗效相同,但1周疗程方案疗程短,病人依从性好,费用减半,效-价比优于2 周疗程方案。     

根除幽门螺杆菌对出血性十二指肠溃疡自然病程影响的3年随访研究

目的：探讨根除幽门螺杆菌（Ｈｐ）对出血性十二指肠溃疡自然病程的影响。方法：选择胃镜证实的出血性十二指肠溃疡病人１３６例，均有Ｈｐ感染（胃粘膜Ｇｉｅｍｓａ染色和１４Ｃ尿素呼吸试验二项均阳性）。予奥米拉唑２０ｍｇ，每日２次；羟氨苄青霉素７５０ｍｇ，每日２次；甲硝唑４００ｍｇ，每日３次，疗程２周。疗程结束后４周复查胃镜和Ｈｐ，溃疡愈合者分Ａ组（Ｈｐ根除）和Ｂ组（Ｈｐ未根除）进入随访阶段，随访观察３年。结果：溃疡愈合１２４例（９１２％），Ｈｐ根除１１１例（８１６％）；Ｈｐ根除的溃疡愈合率为９９１％（１１０／１１１），显著高于Ｈｐ未根除的５６％（１４／２５，Ｐ＜０００５）；Ｂ组１年内溃疡复发率达１００％，显著高于Ａ组８３％（Ｐ＜００５）；Ｂ组３年累积再出血率１００％，显著高于同期Ａ组的９０％（Ｐ＜００５）。结论：根除Ｈｐ可提高十二指肠溃疡愈合率和减少溃疡复发率，尤可显著减少溃疡再出血率，提示根除Ｈｐ很可能改变出血性十二指肠溃疡的自然病程。     

Cure of Helicobacter pylori-positive active duodenal ulcer patients: a double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy. GISU (Interdisciplinary Group for Ulcer Study).

AIMS: To compare a two-week dual therapy to a one-week triple therapy for the healing of duodenal ulcer and the eradication of the Helicobacter pylori infection. PATIENTS AND METHODS: A total of 165 patients with active duodenal ulcer were enrolled in the study. At entry, endoscopy, clinical examination and laboratory tests were performed. Histology and the rapid urease test were used to diagnose Helicobacter pylori infection. Patients received either lansoprazole 30 mg plus amoxycillin 1 g bid for two weeks (two-week, dual therapy) or lansoprazole 30 mg plus amoxycillin 1 g plus tinidazole 500 mg bid for one week plus lansoprazole qd for an additional week (one-week, triple therapy). Two and twelve months after cessation of therapy, endoscopy and clinical assessments were repeated. RESULTS: Duodenal ulcer healing and Helicobacter pylori eradication were both significantly greater (p<0.0001) in the triple therapy group (healing: 98.6%; Helicobacter pylori cure rate: 72.6%) than in the dual therapy group (healing: 77.3%; Helicobacter pylori cure rate: 33.3%). Ulcers healed more frequently in Helicobacter pyloricured than in Helicobacter pylori-not cured patients (94.9% vs. 77.2%; p<0.0022). After one year, Helicobacter pylori eradication was re-confirmed in 46/58 patients previously treated with the triple therapy and in 10/40 patients treated with the dual therapy [p<0.0001]. Only three duodenal ulcer relapses were observed throughout follow-up: all were in Helicobacter pylori-not cured patients. CONCLUSIONS: Triple therapy was more effective than dual both in curing Helicobacter pylori infection and healing active duodenal ulcers. The speed of ulcer healing obtained after only 7 days of antibiotics and 14 days of proton pump inhibitors confirmed that longer periods of anti ulcer therapy were not necessary. Helicobacter pylori -not cured patients had more slowly healing ulcers which were more apt to relapse when left untreated.     

Prolonging proton pump inhibitor-based anti-Helicobacter pylori treatment from one to two weeks in duodenal ulcer: is it worthwhile?

AIMS: To compare the efficacy of one-week versus two-week treatment with lansoprazole, amoxycillin and clarithromycin in inducing healing of Helicobacter pylori-positive duodenal ulcers as well as to investigate the role of several factors, determinant in the ulcer healing process. PATIENTS AND METHODS: Seventy-one active duodenal ulcer patients were randomised to receive one- or two-week treatment with lansoprazole (30 mg bid), clarithromycin (500 mg bid) and amoxycillin (1 g bid), not followed by any additional acid suppressive therapy. Ulcer healing and Helicobacter pylori infection were assessed by endoscopy and urea breath test 4 weeks after the end of treatment. Before entering the trial and four weeks after the end of treatment, dyspeptic symptoms were recorded and scored by a validated questionnaire. The potential effects of a number of clinical variables on the ulcer healing process were evaluated by means of univariate and multivariate analyses. RESULTS: Duodenal ulcer was healed in 80.5% patients treated for one week and in 91.4% patients treated for 2 weeks according to intention-to-treat analysis (p=NS). Ulcer healing was more frequent in the Helicobacter pylori cured patients compared to those with persisting infection (90.9% vs 68.5%; p=0.04). Multivariate analysis did not reveal any significant predictor of duodenal ulcer healing. CONCLUSIONS: Two-week treatment with lansoprazole, amoxycillin and clarithromycin, without continuation of antisecretive therapy, is better, although the difference is not statistically significant, than one-week treatment in healing Helicobacter pylori-positive duodenal ulcer disease. The eradication of Helicobacter pylori is the most important factor related to ulcer healing.     

Amoxicillin plus omeprazole versus triple therapy for eradication of Helicobacter pylori in duodenal ulcer disease: a prospective, randomized, and controlled study.

Treatment with amoxicillin and omeprazole resulted in encouraging Helicobacter pylori eradication rates in pilot studies that included medium term follow up. These results were evaluated in a prospective, randomised and controlled study. Forty patients with active duodenal ulcer disease and H pylori colonisation of the gastric mucosa were randomly assigned to receive either omeprazole (20 mg twice daily) and amoxicillin suspension (500 mg four times daily) for two weeks (group I) or bismuth subsalicylate (600 mg three times daily), metronidazole (400 mg three times daily), tetracycline (500 mg three times daily), and ranitidine (300 mg in the evening) for two weeks (group II). Study medication was followed in both groups by a four week treatment course with 300 mg ranitidine up to the final examination. One patient from each group was lost to follow up. H pylori was eradicated in 78.9% of group I and 84.2% of group II (p = 1.00). All ulcers in patients on omeprazole plus amoxicillin healed but in the triple treatment group four patients had residual peptic lesions after six weeks (ulcer healing rate: 78.9%, p = 0.11). Complete pain relief occurred after a median duration of 1 day in group I and of 6 days in group II (p = 0.03). There were no major complications in either group but minor side effects were more frequently recorded in patients on triple therapy (63.2% v 15.8%, p < 0.01). In conclusion, two weeks of treatment with omeprazole plus amoxicillin is as good as triple therapy plus ranitidine in eradicating H pylori but seems better with regard to safety, pain relief, and ulcer healing. Thus, amoxicillin plus omeprazole should be recommended as the treatment of choice in eradicating H pylori in patients with duodenal ulcer disease.     

Effect of omeprazole and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the healing of duodenal ulcer: comparison with a historical control.

BACKGROUND/AIMS: To test the hypothesis of equivalence of an omeprazole 7-day triple therapy without subsequent acid suppression and a historical ranitidine 12-day triple therapy (recruiting phase 1989-91) with subsequent acid suppression in their effect on the eradication of Helicobacter pylori (H. pylori) and the healing of duodenal ulcer. METHODOLOGY: Seventy-seven patients with H. pylori-positive duodenal ulcers received a 7-day treatment with amoxicillin 750 mg tid and metronidazole 500 mg tid. Additional omeprazole 20 mg or 40 mg once daily was given to 39 and 38 of the patients, respectively. Endoscopy was performed before treatment and four weeks after cessation of therapy. RESULTS: The cumulative intention-to-treat (ITT) H. pylori-eradication rate was 66% (51/77) as compared to 89% (46/52) for the historical control (p < 0.05). The corresponding ulcer healing rates were 90% (69/77) and 92% (48/52). Primary metronidazole resistance (PMR) had escalated from 10% to 27% within 6 years resulting in eradication rates of 84% for sensitive and 19% for resistant strains (p < 0.001). PMR could be demonstrated in 45% of all female, but only in 17% of the male patients (p < 0.05). In the patients with H. pylori eradication, the ulcers healed in 98% (50/51) as compared to 73% (19/26) in those with persistent infection (p < 0.005). Analysis based on the presence of PMR showed ulcer healing rates of 95% (53/56) for sensitive and 76% (16/21) for resistant strains (p < 0.05). Improvement of pain also showed a significant correlation with successful eradication. H. pylori-eradication, healing and symptom relief were similar in the omeprazole 20 mg and 40 mg groups. CONCLUSIONS: The effect of amoxicillin plus metronidazole plus antisecretory agent on the eradication of H. pylori has decreased markedly during the past 6 years due to the escalation of PMR. Doubling of the omeprazole dose does not affect outcome. Cure of the infection as well as metronidazole susceptibility enhance duodenal ulcer healing and symptom relief. Acid suppression following a successful 1-week anti-HP therapy is not required for duodenal ulcer treatment.     

One-Week Antibiotics versus Maintenance Acid Suppression Therapy for Helicobacter pylori-Associated Peptic Ulcer Bleeding

Bleeding peptic ulcer is the most importantcause of upper gastrointestinal bleeding. Our aim was tocompare the effect of anti-Helicobacter therapy withmaintenance treatment of H₂-receptorantagonist in the prevention of relapses of ulcer andbleeding. Patients with bleeding duodenal or gastriculcers and H. pylori infection were randomized toreceive either a one-week course of triple therapy with bismuth subcitrate, metronidazole, andtetracycline plus ranitidine or a six-week course ofranitidine 300 mg/day. After the ulcers healed, theantibiotic-treated patients were not given anymedication, whereas the ranitidine-treated patientscontinued to receive a maintenance dose of 150 mg/day.One hundred twenty-six patients were randomized toreceive anti- Helicobacter therapy and 124 patients toreceive long-term ranitidine. H. pylori eradication wasachieved in 98.2% in those who received triple therapyand 6.1% in those who received ranitidine (P <0.0001). At the six-week follow-up, ulcer healing was documented in 88.2% in those who receivedtriple therapy and 86.1% in those who receivedranitidine (P = 0.639). Recurrent ulcer developed innine of the ranitidine-treated patients and three ofthem presented with recurrent upper gastrointestinal bleeding.One patient in the antibiotic group developed recurrentulcer without rebleeding (P = 0.01). It is concludedthat eradication of H. pylori is sufficient for the prevention of recurrent bleedingulcers.     

One week of treatment with esomeprazole-based triple therapy eradicates Helicobacter pylori and heals patients with duodenal ulcer disease.

BACKGROUND: Proton pump inhibitor (PPI) monotherapy is commonly continued for 3 weeks after Helicobacter pylori eradication with PPI-based triple therapy regimens to ensure duodenal ulcer (DU) healing. This randomized, double-blind, multicentre study evaluated whether only 1 week of triple therapy with the new PPI esomeprazole was sufficient to ensure high rates of ulcer healing and H. pylori eradication. METHODS: A total of 446 H. pylori-positive patients with active DU received twice daily treatment with esomeprazole 20 mg (n = 222) or omeprazole 20 mg (n = 224) in combination with amoxicillin 1 g and clarithromycin 500 mg for 1 week (EAC and OAC, respectively). Patients in the OAC group then received 3 weeks' monotherapy with omeprazole 20 mg once daily; those treated with EAC received placebo. Ulcer healing was assessed by endoscopy on completion of therapy and H. pylori status was assessed by (13)C-urea breath testing and histology 4-6 weeks later. RESULTS: Ulcer healing rates (95% CI) for intention-to-treat and per-protocol populations were: EAC + placebo 91% (87-95%) and 94% (90-97%); OAC + omeprazole 92% (88-95%) and 96% (92-98%). Corresponding H. pylori eradication rates were: EAC + placebo 86% (81-90%) and 89% (84-93%); OAC + omeprazole 88% (83-92%) and 90% (85-93%). Both eradication regimens were well tolerated, and patient compliance was high. CONCLUSIONS: A 1-week regimen of esomeprazole-based triple therapy is sufficient for DU healing and H. pylori eradication in patients with DU disease.     

Comparative study of modified-release clarithromycin and immediate-release clarithromycin in the treatment of Helicobacter pylori-associated peptic ulcer disease

BACKGROUND/AIMS: Proton pump inhibitor-based triple therapy containing immediate-release clarithromycin is an important regimen for the eradication of Helicobacter pylori (H. pylori). However, the efficacy of modified-release clarithromycin for the treatment of H. pylori-associated peptic ulcer disease is still unknown. The aims of the study were to compare the efficacy of modified-release clarithromycin and immediate-release clarithromycin on the rates of ulcer healing and eradication of H. pylori. METHODOLOGY: One hundred and sixty-one patients with Helicobacter pylori-associated peptic ulcer were randomized to receive one-week triple therapy with either modified-release clarithromycin 1000mg once daily (AECMR) or immediate-release clarithromycin 500mg twice daily (AECIR) in combination with amoxicillin 1,000mg twice daily (A) and esomeprazole 40mg once daily (E). Post-treatment ulcer healing status and Helicobacter pylori status was determined by endoscopy and 13C urea-breath test at 16 weeks and 8 weeks after completion of triple therapy, respectively. RESULTS: Helicobacter pylori eradication rates were 87.5% and 87.7% for AECMR and AECIR, respectively, in the intent-to-treat analysis. Eradication rates in the per-protocol groups were 90.3% and 91.4% for AECMR and AECIR, respectively. In both the intent-to-treat and per-protocol analyses, the eradication rates were comparable in the AECMR and AECIR groups (p= 1.0 and 1.0, respectively). Ulcer healing rates in the intention-to-treat analysis were 81.3% and 77.8% for AECMR and AECIR, respectively. Ulcer healing rates in the per-protocol analysis were 90.3% and 90.0% for AECMR and AECIR groups, respectively. In both the intention-to-treat and per-protocol analyses, the ulcer healing rates were comparable in the AECMR and AECIR groups (p=0.645 and 0.584, respectively). CONCLUSIONS: Modified-release clarithromycin 1000mg once daily can be used as an alternative to immediate-release clarithromycin 500mg twice daily for the treatment of Helicobacter pylori-associated peptic ulcer disease.     

Density of Helioobacterpylo／Ymay affect the efficacy of eradication therapy and ulcer healing in patients with active duodenal ulcers

AIM: To evaluate the association of pre-treatment Helicobacter pylori (H. pylori) density with bacterial eradication and ulcer healing rates in patients with active duodenal ulcer. METHODS: One hundred and four consecutive duodenal ulcer outpatients with H. pylori infection ascertained by gastric histopathology and (13)C-urea breath test (UBT) were enrolled in this study. H. pylori density was graded histologically according to the Sydney system (normal, mild, moderate, and marked). In each patient, lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) were used for 1 week, then 30 mg lansoprazole once daily was continued for an additional 3 weeks. Follow-up endoscopy was performed at 4 weeks after completion of the therapy, and UBT was done at 4 and 8 weeks after completion of the therapy. RESULTS: The H. pylori eradication rates were 88.9 %/100.0 %, 94.3 %/100.0 %, and 69.7 %/85.2 %; and the ulcer healing rates were 88.9 %/100.0 %, 94.3 %/100.0 %, and 63.6 %/77.8 % (intention-to-treat/per protocol analysis) in the mild, moderate, and marked H. pylori density groups, respectively. The association of pretreatment H. pylori density with the eradication rate and ulcer healing rate was both statistically significant (P=0.013/0.006 and 0.002/<0.001, respectively; using results of intention-to-treat/per protocol analysis). CONCLUSION: Intragastric bacterial load may affect both the outcome of eradication treatment and ulcer healing in patients with active duodenal ulcer disease.     

Dual therapy versus triple therapy forHelicobacter pylori-associated duodenal ulcers

We compared the ulcer healing effect and eradication ofH. pylori by one-week triple therapy of bismuth, metronidazole, and tetracycline with two-week dual therapy of amoxicillin and omeprazole. One hundred twelve patients with confirmedH. pylori infection and duodenal ulcers were recruited in a prospective, randomized, single-blinded trial. Ulcer healing, eradication ofH. pylori in the stomach six weeks after randomization, and side effects reported by patients during the therapy. Duodenal ulcers were healed in 44 of 49 (89.8%, 95% CI 81.3–98.3%) patients receiving triple therapy and in 44 of 53 (83.0%, 95% CI 72.9–93.1%) patients receiving dual therapy (P=0.32).H. pylori was successfully eradicated in 41 of 49 (83.6%, 95% CI 73.4–94%) patients and in 40 of 53 (75.5%, 95% CI 63.9–87.1%) patients in the triple therapy group and the dual therapy group respectively (P=0.31). Side effects experienced by patients who received triple therapy were significantly more frequent than those who received dual therapy (P=0.0076). In conclusion, a two-week course of omeprazole and amoxicillin achieves a comparable rate ofH. pylori eradication and ulcer healing with fewer side effects.     

Triple therapy for 7 days vs. triple therapy for 7 days plus omeprazole for 21 days in treatment of active duodenal ulcer with Helicobacter pylori infection: A double blind placebo controlled trial

BACKGROUND: The current treatment for active duodenal ulcer implies a 4 weeks course with anti-secretory drugs and two antibiotics for 7 to 10 days in the case of Helicobacter pylori infection. AIM: To establish whether triple therapy with omeprazole given for 7 days with two antibiotics eradicates H. pylori, heals and prevents ulcer recurrence. PATIENTS AND METHODS: A total of 103 patients with active duodenal ulcer and H. pylori were randomly divided into: a group of 50 patients treated with omeprazole, clarithromycin and tinidazole for 7 days followed by omeprazole for 21 days, and a group of 53 patients who received the same treatment as the previous group, followed by placebo for 21 days. Endoscopy with quick urease test, histology and culture was performed at entry and after 4 and 16 weeks. RESULTS: Ulcer healing rate after 16 weeks' treatment was 95% in the former and 96% in the latter group (ns). Eradication after 16 weeks was 84% in the former and 83% in the latter group (ns). At 56 weeks, all patients examined were ulcer free and without H. pylori. CONCLUSION: Omeprazole, clarithromycin and tinidazole for 7 days heals active duodenal ulcer and eradicates H. pylori infection in most patients. Treatment extension with omeprazole, for 3 weeks, after triple therapy does not modify healing and eradication rates.     

Clinical evaluation of four one-week triple therapy regimens in eradicating Helicobacter pylori infection

AIM: To evaluate clinical efficacy of four one-week triple therapies in eradicating Helicobacter pylori infection. METHODS: In this clinical trial, 132 patients with duodenal ulcer and chronic gastritis were randomly divided into four groups, and received treatment with OAC (omeprazole 20 mg + amoxicillin 1 000 mg + clarithromycin 250 mg), OFC (omeprazole 20 mg + furazolidone 100 mg + clarithromycin 250 mg), OFA (omeprazole 20 mg + furazolidone 100 mg + amoxicillin 1 000 mg) and OMC (omeprazole 20 mg + metronidazole 200 mg + clarithromycin 250 mg), respectively. Each drug was taken twice daily for one week. The (13)C urea breath test was carried out 4-8 weeks after treatment to determine the success of H pylori eradication. RESULTS: A total of 127 patients completed the treatment. The eradication rate for H pylori infection was 90.3%, 90.9%, 70.9% and 65.6%, respectively in OAC, OFC OMC and OFA groups. CONCLUSION: A high eradication rate can be achieved with one-week OAC or OFC triple therapy. Thus, one-week triple therapies with OAC and OFC are recommended for Chinese patients with duodenal ulcers and chronic gastritis.     

A randomized controlled comparison of three quadruple therapy regimens in a population with low Helicobacter pylori eradication rates

BACKGROUND AND AIM: We sought to compare the efficacy and tolerability of an omeprazole/clarithromycin/bismuth/tetracycline-based quadruple therapy to that of a ranitidine/metronidazole/bismuth/tetracycline-based quadruple therapy of 2 or 3 weeks duration in a population with a high prevalence of metronidazole-resistant Helicobacter pylori and low triple therapy eradication rates. METHODS: Two hundred and twenty-one patients who presented endoscopically proven duodenal ulcers and a positive rapid urease test were randomized to receive either: (i) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d (OCBT) for 2 weeks; (ii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT2) for 2 weeks; or (iii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT3) for 3 weeks. Patients were interviewed 2 weeks after the completion of therapy to review compliance and side-effects. Eradication of H. pylori was assessed 8 weeks after the completion of therapy with the use of a 14C-urea breath test. RESULTS: The per-protocol eradication rate was significantly higher with OCBT (88%) than RMBT2 (73%) or RMBT3 (71%) (P<0.05). The intent-to-treat eradication rate was numerically higher with OCBT (80%) than RMBT2 (68%) or RMBT3 (68%), although this difference did not reach statistical significance (P=0.09). Per-protocol or intent-to-treat eradication rates were similar with RMBT2 and RMBT3. There were significantly greater side-effects with the RMBT2 regimen. CONCLUSIONS: The omeprazole/clarithromycin/bismuth/tetracycline-based quadruple therapy provides higher H. pylori eradication rates than the ranitidine/metronidazole/bismuth/tetracycline-based quadruple therapy when administered per protocol. The prolongation of the latter regimen from 2 to 3 weeks did not increase eradication rates.